Radiation versus Observation following surgical resection of Atypical Meningioma: a randomised controlled trial (the ROAM trial)

The Walton Centre NHS Foundation Trust (UK)0 个研究点目标入组 157 人开始时间: 2014年5月19日最近更新: 2022年8月15日

适应症

试验速览

2015 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/26576533 protocol 2020 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/32045067 qualiatative analysis (added 12/02/2020)

•Current inclusion criteria as of 03/05/2017:
•1. Histologically confirmed newly diagnosed solitary atypical meningioma (WHO grade II) based on the 2016 WHO criteria
•2. Age >/= 16 years
•3. All anatomical locations allowed except optic nerve sheath tumour
•4. Complete resection (Simpson 1, 2 or 3) as assessed by the surgeon
•5. Able to commence radiotherapy between within 12 weeks of surgery (ideally 8-12 weeks)
•6. WHO performance status 0, 1 or 2
•7. Women of reproductive potential must use effective contraception for the whole duration of the treatment
•8. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
•Previous inclusion criteria:
•1. Histologically confirmed newly diagnosed solitary atypical meningioma (WHO grade II) based on the 2007 WHO criteria
•2. Age 16 years or over
•3. All anatomical locations allowed except optic nerve sheath tumour
•4. Complete resection (Simpson grade I, II or III) as assessed by the surgeon
•5. Able to commence radiotherapy between 8 and 12 weeks after surgery
•6. WHO performance status 0-2

•Current exclusion criteria as of 05/04/2019:
•1. Neurofibromatosis type II (NF-2)
•2. Optic nerve sheath tumours
•3. Multiple meningiomas
•4. Radiation-induced meningioma
•5. Clinical evidence of second malignancy, except for cervix carcinoma in situ or basal cell carcinoma, and history of invasive malignancy unless treated with curative intent and the patient has been disease free for the last five years
•6. Previous intracranial tumour in the last 10 years treated with radiotherapy or chemotherapy
•7. Pregnant or lactating women.
•Previous exclusion criteria as of 03/05/2017:
•1. Neurofibromatosis type II (NF-2)
•2. Optic nerve sheath tumours
•3. Multiple meningiomas
•4. Radiation-induced meningioma
•5. Clinical evidence of second malignancy, except for cervix carcinoma in situ or basal cell carcinoma, and history of invasive malignancy unless treated with curative intent and the patient has not been disease free for the last five years
•6. Previous intracranial tumour
•7. Pregnant or lactating women
•Previous exclusion criteria:
•1. Neurofibromatosis type II (NF-2)
•2. Multiple meningiomas
•3. Previous radiotherapy to the brain or meninges interfering with the protocol treatment plan
•4. Clinical evidence of second malignancies, except a history of cervix carcinoma in situ and/or basal cell carcinoma
•5. Pregnant or lactating women

发起方

The Walton Centre NHS Foundation Trust (UK)